Impact Loading Effect on Bone Biomarkers in Female Runners

NCT ID: NCT05341700

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-24
• Study Completion Date: 2024-04-12

Brief Summary

This study is a randomized, cross-over intervention study that will evaluate the effect of brief, high-impact loading exercises on biomarkers of bone metabolism in energy-restricted female runners. Volunteers will complete two 5-day experimental conditions in a randomized order separated by one menstrual cycle (approximately 3 weeks). Experimental conditions will include a dietary intervention of energy intake equal to 30 kcal/kg of fat-free mass/d using controlled diets and an exercise intervention of daily treadmill running with or without an additional 50 impact loading exercises.

Detailed Description

Many long-distance runners struggle to consume enough calories each day to match the number of calories they are burning during exercise and as part of daily living. Undereating for long periods of time is a serious concern because it can have negative effects on general health and sports performance. One of these long-term consequences is related to bone health. With undereating, bone can start to be broken down faster than it can be rebuilt. Even though it can take months, and even years, for bone to be seriously affected, this may lead to weak and brittle bones later in life, if it is left untreated. Typically, athletes are recommended to increase the number of calories they eat to prevent negative health concerns. However, not all athletes may be willing or able to increase their calories based on their performance goals, nutrition knowledge, or concerns with food security. This means that alternative strategies need to be investigated to counteract the negative effects of undereating on bone health. This study proposes to evaluate the effect of adding short bouts of high-impact jumping exercises to typical endurance training to promote healthy bone metabolism. This will specifically involve completing two phases of a supervised treadmill run and consuming a reduced-calorie diet (provided by the research team) on 5 consecutive days. In addition, one of the phases will include performing 5 sets of 10 jumping exercises on 5 consecutive days in addition to the treadmill run. Results of the study will serve as an important first step in helping exercise and medical professionals understand more about how to protect and manage the bone health of female long-distance runners.

Conditions

Relative Energy Deficiency in Sport

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Endurance and Jumping Exercises

5 days of endurance treadmill running and 5 sets of 10 jumping exercises

Group Type: EXPERIMENTAL

Impact Load Exercises

Intervention Type: BEHAVIORAL

Participants will complete 50-65 min running protocol on treadmill and 5 sets of 10 jumping exercises for 5 consecutive days. Participants will also be provided all meals and snacks to induce a energy-restricted state for the 5-day period.

Endurance Exercise Only

5 days of endurance treadmill running

Group Type: ACTIVE_COMPARATOR

No Impact Load Exercises

Intervention Type: BEHAVIORAL

Participants will complete only a 50-65 min running protocol on treadmill for 5 consecutive days. Participants will also be provided all meals and snacks to induce a energy-restricted state for the 5-day period.

Interventions

Impact Load Exercises

Participants will complete 50-65 min running protocol on treadmill and 5 sets of 10 jumping exercises for 5 consecutive days. Participants will also be provided all meals and snacks to induce a energy-restricted state for the 5-day period.

Intervention Type: BEHAVIORAL

No Impact Load Exercises

Participants will complete only a 50-65 min running protocol on treadmill for 5 consecutive days. Participants will also be provided all meals and snacks to induce a energy-restricted state for the 5-day period.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Females runners with regular menstrual cycles, not using contraceptives
• Body Mass Index between 18.5-30.0 kg/m2
• Weight stable (+/- 2 kg) for 6 months
• VO2max of ≥35 ml/kg/min
• Willing to consume provided meals and snacks

Exclusion Criteria

• Low Energy Availability in Females Questionnaire (LEAF-Q) score ≥8
• Menstrual disturbances measured by progesterone and self-report
• Using contraceptives (oral contraceptives, injections, intrauterine device, etc.)
• Low Bone Mineral Density (z-score < -1)
• Routine engagement in mechanical loading exercises
• History of fracture in the previous 6 months
• Recent recovery (within the last 12 months) or still in recovery after eating disorder diagnosis
• Medication use that could affect bone metabolism (e.g., corticosteroids, anticonvulsants, heparin, gonadotropin-releasing hormone agonists)
• Pregnancy or lactation
• Abnormal thyroid-stimulating hormone levels

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Dawnine Enette Larson-Meyer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enette Larson-Meyer, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University (Virginia Tech)

Locations

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

22-168

Identifier Type: -

Identifier Source: org_study_id